Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00630110




Registration number
NCT00630110
Ethics application status
Date submitted
26/02/2008
Date registered
6/03/2008
Date last updated
16/08/2011

Titles & IDs
Public title
Phase 1/2 Study of Vascular Disrupting Agent NPI-2358 + Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer
Scientific title
Study of the Vascular Disrupting Agent NPI-2358 in Combination With Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer
Secondary ID [1] 0 0
NPI-2358-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - docetaxel
Treatment: Drugs - NPI-2358 + docetaxel

Active comparator: docetaxel - docetaxel (75 mg/m2)

Experimental: NPI-2358 + docetaxel - NPI-2358 (30 mg/m2) + docetaxel (75 mg/m2)


Treatment: Drugs: docetaxel
docetaxel (75 mg/m2)

Treatment: Drugs: NPI-2358 + docetaxel
NPI-2358 (30 mg/m2) + docetaxel (75 mg/m2)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Compare overall survival of patients treated with docetaxel to patients treated with docetaxel + NPI-2358
Timepoint [1] 0 0
Continuous
Secondary outcome [1] 0 0
Compare response rate, duration of response, 6-month survival, progression free survival and safety.
Timepoint [1] 0 0
Continuous
Secondary outcome [2] 0 0
Pharmacokinetics
Timepoint [2] 0 0
Continuous

Eligibility
Key inclusion criteria
* Male and females = 18 years of age
* ECOG performance status = 1
* Pathologically or histologically confirmed advanced non-small cell lung cancer (unresectable Stage IIIb or IV) that has progressed after treatment with at least one chemotherapy regimen; measurable disease is not required for enrollment into this trial
* All Adverse Events of any prior chemotherapy, surgery, or radiotherapy, must have resolved to Grade = 2
* Signed informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Administration of certain chemotherapy, biological, immunotherapy, radiation therapy, surgery or investigational agent within specified time frames
* Significant cardiac history
* Prior treatment with tumor vascular disruptive agents
* Seizure disorder
* Brain metastases
* Active uncontrolled bacterial, viral, or fungal infection, requiring systemic therapy
* Known infection with human immunodeficiency virus (HIV), or active hepatitis A, B, or C
* Patients with a prior hypersensitivity reaction to product components
* Pregnant or breast-feeding women.
* Concurrent, active second malignancy for which the patient is receiving therapy, excluding basal cell carcinoma of the skin or carcinoma in situ of the cervix
* Unwilling or unable to comply with procedures required in this protocol

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2011
Sample size
Target
Accrual to date
Final
172
Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
Recruitment hospital [1] 0 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [2] 0 0
Bendigo Health Care Group - Bendigo
Recruitment hospital [3] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment postcode(s) [2] 0 0
- Bendigo
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
Argentina
State/province [6] 0 0
Bahia Blanca
Country [7] 0 0
Argentina
State/province [7] 0 0
Capital Federal
Country [8] 0 0
Argentina
State/province [8] 0 0
Cordoba
Country [9] 0 0
Argentina
State/province [9] 0 0
Rosario
Country [10] 0 0
Brazil
State/province [10] 0 0
Barretos
Country [11] 0 0
Brazil
State/province [11] 0 0
Curitiba
Country [12] 0 0
Brazil
State/province [12] 0 0
Ijui
Country [13] 0 0
Brazil
State/province [13] 0 0
Porte Alegre
Country [14] 0 0
Brazil
State/province [14] 0 0
Porto Alegre
Country [15] 0 0
Brazil
State/province [15] 0 0
Sao Paulo
Country [16] 0 0
Chile
State/province [16] 0 0
Santiago
Country [17] 0 0
Chile
State/province [17] 0 0
Valparaiso
Country [18] 0 0
India
State/province [18] 0 0
W. Bengal
Country [19] 0 0
India
State/province [19] 0 0
Bangalore
Country [20] 0 0
India
State/province [20] 0 0
Chennai
Country [21] 0 0
India
State/province [21] 0 0
Hyderabad
Country [22] 0 0
India
State/province [22] 0 0
Jaipur
Country [23] 0 0
India
State/province [23] 0 0
Kolkata
Country [24] 0 0
India
State/province [24] 0 0
Mumbai
Country [25] 0 0
India
State/province [25] 0 0
Pune
Country [26] 0 0
India
State/province [26] 0 0
Vishakhapatnam

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Nereus Pharmaceuticals, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Matthew A Spear, MD
Address 0 0
Chief Medical Officer, Nereus Pharmaceuticals, Inc
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00630110